Clinical effectiveness of drop-in mental health services at paediatric hospitals: A non-randomised multi-site study for children and young people and their families – study protocol

Background Despite the high prevalence of mental health difficulties in children and young people with long-term health conditions (LTCs), these difficulties and experiences are often overlooked and untreated. Previous research demonstrated the effectiveness of psychological support provided via a drop-in mental health centre located in a paediatric hospital. The aim of this prospective non-randomised single-arm multi-centre interventional study is to determine the clinical effectiveness of drop-in mental health services when implemented at paediatric hospitals in England. Methods It is hypothesised that families who receive psychological interventions through the drop-in services will show improved emotional and behavioural symptoms. Outcomes will be measured at baseline and at 6-month follow-up. The primary outcome is the difference in the total difficulties score on the Strengths and Difficulties Questionnaire (SDQ) reported by parent or child at 6 months. Secondary outcomes include self and parent reported Paediatric Quality of Life Inventory (PedsQL), self-reported depression (PHQ-9) and anxiety measures (GAD-7) and family satisfaction (CSQ-8). Discussion This trial aims to determine the clinical effectiveness of providing psychological support in the context of LTCs through drop-in mental health services at paediatric hospitals in England. These findings will contribute to policies and practice addressing mental health needs in children and young people with other long-term health conditions. Trial registration ISRCTN15063954, Registered on 9 December 2022.

contact typically 30 minutes or less, where input can be provided by trained practitioners or supporters [21].These specialised interventions address potential time constraints that patients or hospital services may report, provide a route to administer evidence-based interventions in a more accessible manner that can be helpful for patients that may not meet stringent CAMHS criteria for high intensity interventions, but would still benefit from psychological support.Additionally, given that low intensity interventions do not usually require the same length of training as that required for high intensity intervention, more staff can be trained specifically to provide these services within a solid, evidence-based framework of structured supervision, over a shortened period of time.
A model of delivering low intensity psychological support to families with LTCs is to use a 'drop-in centre' located within a paediatric hospital, offering support at point of need with limited waiting time.Such support includes signposting to existing provision, referral to appropriate services, neurodevelopmental assessments, as well as the provision of low intensity CBT.Previous research indicated that this can be an effective way of providing mental health support for families in the context of LTCs, reducing emotional and behavioural symptoms and improving reported quality of life for CYP and their families [14,22].Despite encouraging evidence, it is important to understand if (and how) this model can be implemented in different paediatric hospitals and services in England.Furthermore, research often fails to quickly translate into routine clinical practice.The implementation of a new intervention can take up to 17 years to be incorporated into practice and it is essential to consider factors that can facilitate this process [23,24].The drop-in services may vary operationally from the original research project, and differ at each new site although key principles will be retained i.e., self-referral, integration with existing services, use of evidence-based interventions, any direct provision being low intensity.The COVID-19 pandemic increased the use of telehealth and digital appointments as hospital footfall dropped [25], therefore the drop-in "centres" will instead operate as drop-in "services" offering face-to-face, digital and telephone appointments depending on patient preference.To roll-out these services researchers will closely work with new hospitals to best understand how this can be delivered within their existing teams, pathways and capacities.

Objectives (7)
The overarching objective of this research is to implement drop-in services for CYP and families with mental health needs in the context of LTCs at various different paediatric hospitals in England.This single-arm trial aims to evaluate the clinical effectiveness of the drop-in services in providing access to mental health support.The drop-in services will be integrated with existing mental health provision and serve as a single point of access delivering evidence-based low intensity psychological interventions or signposting and onward referral where clinically appropriate.

Trial design (8)
This present study is a prospective non-randomised single-arm multi-centre interventional trial investigating the clinical effectiveness of drop-in mental health services at paediatric hospitals.Patients aged up to 25 years old with a LTC, who have been receiving care for their LTC for 6 months or more, and their parent/carer and siblings can take part in the trial.The primary outcome is the difference in the total difficulties score on the Strengths and Difficulties Questionnaire (SDQ) reported by parent or child at 6 months.

Methodology: Participants, interventions and outcomes
The trial was registered at ISRCTN (ISRCTN15063954) on 9th December 2022.The trial was registered two weeks after enrolment began as approval for participating hospitals to begin recruitment was granted sooner than expected and the research team wished to adapt to the hospital's respective timelines.The authors confirm that all ongoing and related trials for this intervention are registered.

Study setting (9)
Recruitment will take place at any of the participating paediatric hospitals in England.For a full list of the participating sites, please visit ISRCTN15063954.

Eligibility criteria (10)
Participants will be eligible to participate in this study if they meet the below inclusion criteria.

Participant inclusion criteria
1. Patients aged between 0-25 years old, or a parent/carer or sibling of the patient.
2. Receiving care for a LTC at one of the participating hospitals.
3. Receiving care for their LTC 6 months or more.

Exclusion criteria.
Participants included in the study analysis cannot be receiving another form of concurrent psychological care from the hospital.Participants are eligible if on a waiting list for psychology support.

Who will take informed consent? (26a)
Consent will be completed online or taken over the phone.The order of referral procedures and the consent process is as follows: 1. Participants will be referred to the drop-in service through different routes depending on their hospital.For instance, self-referrals to the service can be made by using the QR code or email address which are located on posters in the hospitals.CYP can also be referred by their clinician who, upon receiving their consent to contact, can share contact details with the study team.
2. The study team will get in contact with the participant (or parent/carer when appropriate) to provide more information and details of the consent process.
Confidentiality.Identifiable information pertaining to the participant is essential for participant registration.Anonymity will be held unless any information disclosed about the participant indicates that they are in a situation posing risk to themselves or others.If risk is identified, the research team will inform the participant's GP and hospital site.

Intervention description
Once consented and in contact with the research team, the participant will provide demographic information and complete initial baseline measures.
1. Parent-reported Strengths and Difficulties Questionnaire, and/or self-reported for CYP aged 11+ (SDQ) [26] 2. Parent-reported Paediatric Quality of Life Questionnaire, and/or self-reported for CYP aged 8+ (PedsQL) [27] 3. Self-reported Patient Health Questionnaire, for parents and CYP aged 12+ (PHQ-9) [28] 4. Self-reported Generalized Anxiety Disorder Assessment, for parents and CYP aged 12+ (GAD7) [29] After baseline measures and consent have been completed, the participant's GP and hospital site will be informed and consent forms and baseline measures, including any identified risk, will be shared.An assessment appointment with the participant will be set up by the low intensity trained practitioner from the hospital site.This assessment is used to help decide, in collaboration with the family, which intervention allocation is most suitable for the participant.The assessment will be discussed in supervision provided by a clinical psychologist, or a senior low intensity practitioner under the supervision of a clinical psychologist.After this discussion patients will either be assigned to receive an evidence-based low intensity CBT intervention (selected from a set of empirically validated options) or will be signposted or referred to other services in their hospital or local area.If the participant is suitable for low intensity CBT, they will receive weekly sessions face-to-face, over the telephone or over video call depending on participant preference, lasting around 30-45 minutes for 6-8 weeks with a trained practitioner.If a low intensity intervention is deemed to not be the most appropriate allocation for the participant's needs, they will be referred to a different service, such as CAMHS or hospital psychology services, or they will be signposted to external services, for example a charity or non-profit organisation.At six months post baseline assessment an independent researcher will contact participants with follow up questionnaires to be completed over the phone or online.CYP and/or their parents (depending on age) will complete the SDQ, PedsQL, PHQ-9, GAD-7 and a modified Centre Satisfaction Questionnaire (CSQ) [30].This process is outlined in Fig 1.

Patient Public Involvement (PPI)
The Young People's Advisory Group (YPAG) at Great Ormond Street Hospital and the Cambridge Parents' Advisory Group have, and will continue to be, consulted throughout this project.PPI input has been invaluable, providing advice on patient facing materials, online questionnaires and dissemination.Parent and child PPI meetings were held separately to provide a comfortable environment for parents and children to share their opinions and to appreciate the potential differences in questions, concerns, and interests that each group may have.

Criteria for discontinuing or modifying allocated interventions (11b)
When participants consent to the trial, they will be informed that they are consenting to the trial intervention, trial follow-up and data collection.If at any point the following issues occur with a participant, the intervention will be terminated for that participant: • Participant's withdrawal of consent from the trial intervention • Participant's illness inhibits continual engagement with the intervention, in a judgement made from the discretion of the clinician As participation in the trial is entirely voluntary, the participant may choose to discontinue trial treatment at any time without penalty or loss of benefits to which they would otherwise be entitled.

Training and supervision of practitioners
It has been found that a lack of adequate training resources is a possible factor contributing to implementation challenges of low intensity psychological interventions for children and young people [31].To address this issue, the current project has delivered training on low intensity psychological interventions for CYP in the context of LTCs for clinicians from participating hospitals [32].Hybrid training was provided by a clinical psychologist and PhD student over two days to a wide range of clinicians, including non-mental health specialists.The training covered techniques such as information gathering and guided self-help, how to equip patients with LTCs who are experiencing mental health difficulties (and their families) and shared evidence-based low-intensity CBT strategies to improve low mood, anxiety and behavioural difficulties.The training was recorded using Microsoft Teams, making it easily accessible for practitioners to refer back to and for future hospital sites to acquire the training in a timely manner.
Across the different sites, different practitioners will provide low intensity CBT to participants.Experience will vary with some practitioners already qualified low intensity practitioners (and therefore have completed in depth training and have post qualification experience), and others who are new to CBT.Supervision and consultation will be adapted according to experience.total sample size of 120 could detect a small to moderate effect size, at 5% significance level with 80% power, with a loss to follow-up rate of 10%.It is estimated that 10 participants will be recruited each month over a period of 12 months.

Recruitment (15)
Participants will be able to join the study through various routes.Participants can self-refer into the study using the QR code or email address on the poster and newsletters advertising the drop-in service in participating hospitals.Alternatively, participants may be referred to the service through their clinician and after they have provided consent to contact, patient details will be given to the research team.Eligibility criteria will be checked and then participant information sheets can be shared.If interested, participants can then consent to take part and complete baseline measures.After these are collected, an assessment will be organised with a low intensity practitioner, discussed in supervision and appropriate intervention will be allocated.
The aim is for all participants to be offered an assessment within two weeks after consenting to ensure the service is providing "drop-in" support and timely access to treatment.

Assignment of interventions
There are three types of intervention allocations: low intensity CBT, onward referral or signposting (Fig 2).After the practitioner has discussed the assessment with their supervisor, CYP who display mild to moderate emotional and/or behavioural difficulties will be offered low intensity CBT.For CYP where low intensity CBT may not be most clinically appropriate (e.g. if their mental health concern is surrounding adjustment to new condition or a bereavement, or if they have previously had low intensity CBT for the same problem), individuals may be referred to other therapy modalities (such as narrative therapy, family therapy or counselling), or signposted towards other services (e.g., a local support group or charity).Parents or siblings over 25 years old who take part in the study may be offered a one-off CBT session (as practitioners are trained to deliver low intensity CBT sessions for CYP mental health difficulties rather than adult mental health difficulties) or referred or signposted for further support.Regardless of treatment allocation, all participants who consented and completed baseline measures will be followed up after 6 months.

Plans for assessment and collection of outcomes (18a)
Participants that provide consent to take part in the study will be assigned a unique participant identification number.Data collected at baseline and 6-month follow up will be collected over the phone, face-to-face or online using REDcap depending on participants' preferences.RED-Cap [39,40] is a secure electronic data capture and transfer software developed by Vanderbilt University.The software is hosted on virtual servers provided by AIMES (an ISO27001 certified cloud hosting provider) in its own data centre in Liverpool, UK.The software is licenced for use by Vanderbilt University to REDCap consortium members, of which Great Ormond Street Hospital is one.The study data will be stored on secured virtual Linux servers (specifically GOSH-REDCap-DB01, GOSH_REDCap-WB01) with an appropriate level of encryption based in England, UK.All data will be handled in accordance with the General Data Protection Regulation and UK Data Protection Act 2018.

Data management (19)
Each participant will be allocated a unique study number at study entry.They will be identified by this number on all study related documentation throughout the course of the intervention and data analysis process.Any data transferred will be done according to the NHS Code of Practice on Confidentiality.Access to the database is controlled by password-protected accounts, and an individual's access to the database is restricted by their role.

Plans to promote participant retention and complete follow-up (18b)
The importance of attending intervention sessions and completing follow-up measures will be explained to all participants at the start of the study.Participants who discontinue treatment should remain in the study for the purpose of follow-up and data analysis.They will be asked whether they continue to consent to being contacted for follow-up measures.Data will be analysed on an intention-to-treat basis.Therefore, withdrawal from the study will not result in exclusion of the data for that participant from analysis.

Statistical methods for primary and secondary outcomes (20a)
Patient characteristics at baseline will be summarised using mean and standard deviation (SD) for continuous variables which are approximately normally distributed, or median and interquartile range (IQR) for variables which are not normally distributed, or by frequencies and percentages for categorical variables.All statistical hypothesis tests will use a two-sided p-value of 0.05 unless otherwise specified.All confidence intervals (CIs) presented will be 95% and two-sided.All statistical analysis will be performed using SPSS statistics analysis software (V.25, IBM) or an alternative package.